Oncology | Phase I Developments | Pipeline Prospector

Sutro Biopharma

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United States

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Sutro Biopharma Announces Pricing of $85.3 Million Public Offering

Lead Product(s): STRO-001

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Cowen

Deal Size: $85.3 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 11, 2020

Details:

Sutro intends to use the net proceeds together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002.

INmune Bio

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INmune Bio Inc’s INB03 Inhibits Cell Migration, Tumor Growth in Pre-clinical Models of Trastuzumab-Resistant HER2+ Breast Cancer

Lead Product(s): INB03

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

Study provides rational for use of INB03 and Lapatinib in INmune Bio’s upcoming Phase II trial and may offer new therapy for women with CNS metastasis from HER2+ breast cancer.

TRACON Pharmaceuticals

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United States

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TRACON Pharmaceuticals Announces Successful Type B Meeting with FDA for Pivotal Study of Envafolimab in Sarcoma

Lead Product(s): KN035,Ipilimumab

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

FDA agreed with TRACON’s proposals on key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma.

Nanobiotix

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FRANCE France

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NANOBIOTIX Announces First Phase I Trial With NBTXR3 in Pancreatic Cancer Is Safe to Proceed Per US FDA

Lead Product(s): Hafnium dioxide

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

The trial is a phase I dose escalation study evaluating the safety & feasibility of NBTXR3 activated by radiation therapy in locally advanced or borderline-resectable pancreatic ductal adenocarcinoma.

Bexion Pharmaceuticals

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Bexion Pharmaceuticals Receives Orphan Drug Designation for BXQ-350 for Malignant Glioma from FDA

Lead Product(s): Saposin C-dioleoylphosphatidylserine

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

U.S FDA has granted Bexion Pharmaceuticals an Orphan Drug Designation for its proprietary drug, BXQ-350, for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG).

Lineage Cell Therapeutics

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United States

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Lineage Cell Therapeutics Announces Early Exercise of Option with Cancer Research UK for Immuno-Oncology Cell Therapy Program

Lead Product(s): AST-VAC2

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

Cancer Research UK has permitted Lineage to conduct an early exercise of its option to acquire data from Cancer Research UK’s ongoing Phase 1 clinical trial of VAC2 in non-small cell lung cancer.

InteRNA Technologies

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Netherlands

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InteRNA Technologies Receives Regulatory Approval for Initiation of Phase I Clinical Trial of INT-1B3 in Patients with Advanced Solid Tumors

Lead Product(s): INT-1B3

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 05, 2020

Details:

First-in-human trial will test the safety, pharmacokinetics and preliminary efficacy of microRNA therapeutic candidate INT-1B3.

Scholar Rock

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United States

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Scholar Rock Announces Initiation of Patient Dosing in Phase 1 Proof-of-Concept Immuno-Oncology Trial of SRK-181

Lead Product(s): SRK-181

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 05, 2020

Details:

Dosing of patients with locally advanced or metastatic solid tumors has commenced in the DRAGON Phase 1 clinical trial of SRK-181, a highly specific inhibitor of latent TGF-Beta 1 activation.

Clinigen Group

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United Kingdom

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Clinigen Demonstrates IL-2 Plays Role in Emerging TIL Therapies

Lead Product(s): Interleukin 2,Tumor infiltrating lymphocyte,Nivolumab

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

Study aimed at evaluating the safety and efficacy of TIL therapy in metastatic NSCLC (mNSCLC) after evidence of progression on nivolumab.

Oncolytics Biotech

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Oncolytics Biotech® to Present Clinical Findings of Pelareorep-Induced Immune Response in Breast Tumors

Lead Product(s): Pelareorep,Atezolizumab,Letrozole

Therapeutic Area: Oncology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

AWARE-1combines the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer.

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Sutro Biopharma

Sutro Biopharma Announces Pricing of $85.3 Million Public Offering

INmune Bio

INmune Bio Inc’s INB03 Inhibits Cell Migration, Tumor Growth in Pre-clinical Models of Trastuzumab-Resistant HER2+ Breast Cancer

TRACON Pharmaceuticals

TRACON Pharmaceuticals Announces Successful Type B Meeting with FDA for Pivotal Study of Envafolimab in Sarcoma

Nanobiotix

NANOBIOTIX Announces First Phase I Trial With NBTXR3 in Pancreatic Cancer Is Safe to Proceed Per US FDA

Bexion Pharmaceuticals

Bexion Pharmaceuticals Receives Orphan Drug Designation for BXQ-350 for Malignant Glioma from FDA

Lineage Cell Therapeutics

Lineage Cell Therapeutics Announces Early Exercise of Option with Cancer Research UK for Immuno-Oncology Cell Therapy Program

InteRNA Technologies

InteRNA Technologies Receives Regulatory Approval for Initiation of Phase I Clinical Trial of INT-1B3 in Patients with Advanced Solid Tumors

Scholar Rock

Scholar Rock Announces Initiation of Patient Dosing in Phase 1 Proof-of-Concept Immuno-Oncology Trial of SRK-181

Clinigen Group

Clinigen Demonstrates IL-2 Plays Role in Emerging TIL Therapies

Oncolytics Biotech

Oncolytics Biotech® to Present Clinical Findings of Pelareorep-Induced Immune Response in Breast Tumors